Cardiovascular DiseasesNCT06931470
A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities (PRESTO)
A study testing In-person supervised exercise sessions, Virtual classes (live-streamed sessions) and Self-directed aerobic exercise in people with Cardiovascular Diseases, run by NYU Langone Health at 1 site in United States.
Trial summary
This study will investigate the acceptability and efficacy of 12 weeks of: Smart-device app-based (MyZone) Asynchronous Virtual, Synchronous Virtual, and in-person aerobic training in individuals at risk for Cardiovascular Disease (CVD) who do are not meeting American Heart Association (AHA) guidelines for physical… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- In-person supervised exercise sessions, Virtual classes (live-streamed sessions) and Self-directed aerobic exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >45 years
- At risk for CVD (participants must have one or more of the following risk factors: hypertension, hyperlipidemia, Type 2 Diabetes Mellitus, smoking, obesity, family history of premature CVD)
- Not meeting AHA physical activity guidelines for at least 3 months prior to screening
- Hypertension:
- Systolic BP ≥140 mm Hg and/or diastolic BP ≥90 mm Hg and/or
- Use of anti-hypertensive medication
Show all 18Show fewer
- Hyper / dyslipidemia
- LDL cholesterol levels ≥160 mg/dL and/or
- HDL cholesterol <50mg/dL for women, <40mg/dL for women, in addition to fasting triglycerides >150mg/dL
- Diabetes Mellitus:
- Hemoglobin A1c levels ≥6.5%, fasting glucose levels ≥126 mg/dL, or 2-hour glucose levels ≥200 mg/dL after an oral glucose tolerance test and/or
- Use of any diabetes medication
- Smoking:
- o Current regular tobacco use.
- Obesity:
- o BMI ≥30 kg/m².
- Family History of Premature Cardiovascular Disease:
- Having a first-degree relative (parent, sibling) who developed CVD before age 55 for biological males or age 65 for biological females.
Who cannot join
- Established diagnosis of atherosclerotic CVD
- Presence of any serious medical conditions that would not allow safe participation in exercise according to the American College of Sports Medicine (ACSM) and the AHA (56-58)
- Pregnant or anticipating pregnancy
- Plan to be away for >2 weeks during the intervention period
- Presence of any biopsychosocial factors that the principal investigator deems as having significant potential to interfere with effective study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities
This study will investigate the acceptability and efficacy of 12 weeks of: Smart-device app-based (MyZone) Asynchronous Virtual, Synchronous Virtual, and in-person aerobic training in individuals at risk for Cardiovascular Disease (CVD) who do are not meeting American Heart Association (AHA) guidelines for physical activity. The study aims to 1) Assess the effect of several approaches to remote aerobic training on measures of physical activity, cardiovascular fitness and CVD risk, and 2) Quantitatively and qualitatively evaluate exercise training program fidelity, implementation, effectiveness, and remaining barriers to acceptance.
Participants will be asked to undergo Cardiopulmonary Exercise Testing (CPET) before and after 12-weeks of training via one of the 4 modalities (random assignment) listed above. They will respond to questions regarding acceptability of the interventions.
- Conditions
- Cardiovascular Diseases
- Being tested
- In-person supervised exercise sessions, Virtual classes (live-streamed sessions), Self-directed aerobic exercise, Myzone mobile application, Map My Fitness mobile application
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person supervised exercise sessionsBehavioural
Gold-standard, facility-based sessions (3 sessions/week) with an onsite trainer guidance with an exercise Intensity of 40-80% heart rate reserve (HRR) or Rate of Perceived Exertion (RPE) 12-16.
Virtual classes (live-streamed sessions)Behavioural
Live-streamed exercise classes (3 sessions/week) with a trainer providing real-time feedback.
Self-directed aerobic exerciseBehavioural
Participants exercise independently and follow a weekly progression plan (3-5 sessions/week (depending on the specific progression)).
Myzone mobile applicationDevice
Training using the Myzone platform, with participants wearing the Myzone heart rate monitor and using the Myzone app to receive real-time feedback and guidance during exercise sessions (3 days per week). Myzone integrates with its proprietary wearable devices to monitor heart rate and other activity metrics, providing real-time data to users via the app.
Map My Fitness mobile applicationDevice
Participants will wear a Bluetooth-compatible heart rate monitor (e.g., apple watch/fitbit) that syncs with MapMyFitness. MapMyFitness automatically records workout sessions (duration, distance, heart rate, calories burned, and elevation gain where applicable).
Centralized telemetryDevice
Centralized telemetry monitors heart rates and provides immediate feedback for trainers to adjust exercise intensity.
Myzone heart rate monitorDevice
Wearable device (chest strap or armband) that monitors heart rate.
| Study group | Role | What they receive |
|---|---|---|
| In-Person Supervised Aerobic Exercise Intervention (IPSAEI) | Active comparator | Participants engage in supervised exercise sessions at a facility, where trainers use centralized telemetry to monitor heart rates and provide immediate feedback and adjustments to exercise intensity. Receives: Behavioral: In-person supervised exercise sessions; Device: Centralized telemetry |
| Remote Synchronous Aerobic Exercise Intervention (RSAEI) | Experimental | Participants join live-streamed exercise sessions led by a virtual trainer. Real-time heart rate monitoring via an app allows the trainer to provide immediate feedback and adjust exercise intensity as needed. Receives: Behavioral: Virtual classes (live-streamed sessions); Device: Map My Fitness mobile application |
| Asynchronous Remote Aerobic Exercise Intervention (RASAEI) | Experimental | Participants exercise independently while monitoring their heart rate in real time using the Map My Fitness app. They adjust their intensity based on personal targets and receive periodic feedback from a trainer during scheduled check-ins. Receives: Behavioral: Self-directed aerobic exercise; Device: Map My Fitness mobile application |
| Remote MyZone Aerobic Exercise Intervention (RMZAEI) | Experimental | Participants use the Myzone heart rate monitor and app to receive real-time feedback on their exercise intensity. The Myzone platform provides automated guidance on intensity adjustments, goal setting, and motivational support through features like challenges and social connectivity. Receives: Device: Myzone mobile application; Device: Myzone heart rate monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average minutes of moderate to vigorous physical activity per week
Outcome is measured via wearable technology (smart device).
Measured: Up to 13 weeks
Secondary outcomes (6)
Change in peak oxygen consumption (VO2peak)
Peak oxygen consumption (VO2peak) is measured as the highest VO2 recorded during the course of a Cardiopulmonary Exercise Testing (CPET).
Measured: Baseline, Week 13
Change in blood pressure
Measured: Baseline, Week 13
Change in Body mass index (BMI)
BMI (kg/m2) will be calculated using measured body weight and height
Measured: Baseline, Week 13
Change in body fat percentage
Body fat percentage will be assessed via multi-frequency bioelectrical impedance analysis (BIA) with 8 tactile electrodes.
Measured: Baseline, Week 13
Change in fasting glucose levels
Measured: Baseline, Week 13
Change in 36-Item Short Form Survey Instrument (SF-36)
SF-36 captures mental health, general health perception, emotional, and social role functioning. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Higher scores indicate a more favorable health state.
Measured: Baseline, Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start6 Apr 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean P. Heffron, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931470
- Sponsor's protocol ID
- 24-01067
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: \[Alec Sinatro, MD; alec.sinatro@nyulangone.org\]. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility and Acceptability Study of Remote ExerciSe Training mOdalities
- ClinicalTrials.gov ID
- NCT06931470
- Acronym / sponsor ID
- 24-01067
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 6 Apr 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the acceptability and efficacy of 12 weeks of: Smart-device app-based (MyZone) Asynchronous Virtual, Synchronous Virtual, and in-person aerobic training in individuals at risk for Cardiovascular Disease (CVD) who do are not meeting American Heart Association (AHA) guidelines for physical activity. The study aims to 1) Assess the effect of several approaches to remote aerobic training on measures of physical activity, cardiovascular fitness and CVD risk, and 2) Quantitatively and qualitatively evaluate exercise training program fidelity, implementation, effectiveness, and remaining barriers to acceptance.
Participants will be asked to undergo Cardiopulmonary Exercise Testing (CPET) before and after 12-weeks of training via one of the 4 modalities (random assignment) listed above. They will respond to questions regarding acceptability of the interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| In-Person Supervised Aerobic Exercise Intervention (IPSAEI) | Active comparator | Behavioral: In-person supervised exercise sessions, Device: Centralized telemetryParticipants engage in supervised exercise sessions at a facility, where trainers use centralized telemetry to monitor heart rates and provide immediate feedback and adjustments to exercise intensity. |
| Remote Synchronous Aerobic Exercise Intervention (RSAEI) | Experimental | Behavioral: Virtual classes (live-streamed sessions), Device: Map My Fitness mobile applicationParticipants join live-streamed exercise sessions led by a virtual trainer. Real-time heart rate monitoring via an app allows the trainer to provide immediate feedback and adjust exercise intensity as needed. |
| Asynchronous Remote Aerobic Exercise Intervention (RASAEI) | Experimental | Behavioral: Self-directed aerobic exercise, Device: Map My Fitness mobile applicationParticipants exercise independently while monitoring their heart rate in real time using the Map My Fitness app. They adjust their intensity based on personal targets and receive periodic feedback from a trainer during scheduled check-ins. |
| Remote MyZone Aerobic Exercise Intervention (RMZAEI) | Experimental | Device: Myzone mobile application, Device: Myzone heart rate monitorParticipants use the Myzone heart rate monitor and app to receive real-time feedback on their exercise intensity. The Myzone platform provides automated guidance on intensity adjustments, goal setting, and motivational support through features like challenges and social connectivity. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- >45 years
- At risk for CVD (participants must have one or more of the following risk factors: hypertension, hyperlipidemia, Type 2 Diabetes Mellitus, smoking, obesity, family history of premature CVD)
- Not meeting AHA physical activity guidelines for at least 3 months prior to screening
- o Current regular tobacco use.
- o BMI ≥30 kg/m².
Key exclusion criteria (5 listed)
- Established diagnosis of atherosclerotic CVD
- Presence of any serious medical conditions that would not allow safe participation in exercise according to the American College of Sports Medicine (ACSM) and the AHA (56-58)
- Pregnant or anticipating pregnancy
- Plan to be away for >2 weeks during the intervention period
- Presence of any biopsychosocial factors that the principal investigator deems as having significant potential to interfere with effective study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-person supervised exercise sessionsGold-standard, facility-based sessions (3 sessions/week) with an onsite trainer guidance with an exercise Intensity of 40-80% heart rate reserve (HRR) or Rate of Perceived Exertion (RPE) 12-16. | Behavioural | In-Person Supervised Aerobic Exercise Intervention (IPSAEI) |
| Virtual classes (live-streamed sessions)Live-streamed exercise classes (3 sessions/week) with a trainer providing real-time feedback. | Behavioural | Remote Synchronous Aerobic Exercise Intervention (RSAEI) |
| Self-directed aerobic exerciseParticipants exercise independently and follow a weekly progression plan (3-5 sessions/week (depending on the specific progression)). | Behavioural | Asynchronous Remote Aerobic Exercise Intervention (RASAEI) |
| Myzone mobile applicationTraining using the Myzone platform, with participants wearing the Myzone heart rate monitor and using the Myzone app to receive real-time feedback and guidance during exercise sessions (3 days per week). Myzone integrates with its proprietary wearable devices to monitor heart rate and other activity metrics, providing real-time data to users via the app. | Device | Remote MyZone Aerobic Exercise Intervention (RMZAEI) |
| Map My Fitness mobile applicationParticipants will wear a Bluetooth-compatible heart rate monitor (e.g., apple watch/fitbit) that syncs with MapMyFitness. MapMyFitness automatically records workout sessions (duration, distance, heart rate, calories burned, and elevation gain where applicable). | Device | Asynchronous Remote Aerobic Exercise Intervention (RASAEI), Remote Synchronous Aerobic Exercise Intervention (RSAEI) |
| Centralized telemetryCentralized telemetry monitors heart rates and provides immediate feedback for trainers to adjust exercise intensity. | Device | In-Person Supervised Aerobic Exercise Intervention (IPSAEI) |
| Myzone heart rate monitorWearable device (chest strap or armband) that monitors heart rate. | Device | Remote MyZone Aerobic Exercise Intervention (RMZAEI) |
Primary outcome
Average minutes of moderate to vigorous physical activity per week
Time frame: Up to 13 weeks
Outcome is measured via wearable technology (smart device).
6 secondary outcomes
Change in peak oxygen consumption (VO2peak)
Time frame: Baseline, Week 13
Change in blood pressure
Time frame: Baseline, Week 13
Change in Body mass index (BMI)
Time frame: Baseline, Week 13
Change in body fat percentage
Time frame: Baseline, Week 13
Change in fasting glucose levels
Time frame: Baseline, Week 13
Change in 36-Item Short Form Survey Instrument (SF-36)
Time frame: Baseline, Week 13
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: [Alec Sinatro, MD; alec.sinatro@nyulangone.org]. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sean P. Heffron, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person supervised exercise sessions, Virtual classes (live-streamed sessions) and Self-directed aerobic exercise in people with Cardiovascular Diseases, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sean Heffron, MD (857-366-1417, Sean.heffron@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average minutes of moderate to vigorous physical activity per week (time frame: Up to 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.